FDA Adverse Event
Injury
Summary report: N
RIATA ST ACTIVE FIXATION LEAD
MDR report key: 1073581
·
Received July 11, 2008
Report
- Report Number
- 2017865-2008-02465
- Event Type
- Injury
- Date Received
- July 11, 2008
- Date of Event
- May 5, 2008
- Manufacturer
- ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
- Product Code
- LWS
- PMA / PMN Number
- PMA00001
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED.
Description of Event or Problem · 1
DURING FOLLOW-UP, A SENSING ANOMALY WAS OBSERVED. X-RAY SHOWED DEVICE MIGRATION AND LEAD DISLODGMENT. DURING THE REPOSITIONING PROCEDURE, TWIDDLER SYNDROME WAS CONFIRMED. THE LEADS WERE TANGLED AND TWISTED. THE DEVICE AND LEADS WERE REPOSITIONED AND REMAIN IMPLANTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | RIATA ST ACTIVE FIXATION LEAD | DEFIBRILLATION LEAD | LWS | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | 7000/65 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |